| Registry | NCT07847450 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 42 (Estimated) |
| Sponsor | Bezmialem Vakif University (Other) |
| Conditions | Carpal Tunnel Syndrome (CTS) |
| Dates | start 2026-11-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-09-29, last updated 2026-09-29 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Carpal Tunnel Syndrome (CTS)
The aim of this cross-sectional study is to evaluate muscle strength in female patients with carpal tunnel syndrome (CTS) who have only sensory involvement detected on electromyography. Muscle strength will be assessed using the "Lafayette Manual Muscle Tester®".
The main questions of the study are:
1. Is there a difference in muscle strength between healthy individuals and female patients with carpal tunnel syndrome?
2. Is there a difference in muscle strength between female patients with carpal tunnel syndrome who have only sensory involvement and those who have both sensory and motor involvement?
3. Are there differences in the strength of thumb palmar abduction and adduction, radial adduction and abduction, thumb flexion, extension and opposition, and flexion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the fingers between these groups?
The investigators will measure the muscle strength associated with these movements using the "Lafayette Manual Muscle Tester®" in order to objectively evaluate motor involvement in female patients with carpal tunnel syndrome and to compare muscle strength between healthy individuals and patients with different degrees of electrophysiological involvement.
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and develops as a result of compression of the median nerve within the carpal tunnel at the level of the wrist. It manifests with pain in the wrist and hand, paresthesia and sensory loss in the dermatome of the median nerve in the hand (paresthesias may sometimes extend to the entire hand and even the arm), as well as weakness in thumb abduction, opposition, and flexion, and flexion of the second and third fingers at the metacarpophalangeal joints. The carpal tunnel is a structure located in the proximal palmar region of the wrist, bounded superiorly by connective tissue and the carpal ligament and inferiorly by the carpal bones, through which the median nerve and flexor tendons pass. The motor fibers of the median nerve passing through the carpal tunnel innervate the thenar muscle group (abductor pollicis brevis, flexor pollicis brevis-superficial head, and opponens pollicis), as well as the first and second lumbrical muscles; its sensory fibers provide innervation to the first three digits and the lateral aspect of the fourth digit
Among the risk factors for this common entrapment neuropathy are female sex, obesity, age, occupations and activities involving repetitive rotational and flexion movements of the hand, trauma, and pregnancy . The diagnosis of CTS is primarily clinical. It is established based on typical signs and symptoms, such as hand and wrist pain, symptoms occurring or worsening at night, relief with shaking of the hand, and positive Tinel and Phalen signs. Electrophysiological studies (nerve conduction studies and needle electromyography) are used both to confirm the diagnosis of CTS and to exclude other conditions included in the differential diagnosis, such as polyneuropathy, hereditary neuropathy with liability to pressure palsies, and C6 radiculopathy. Nerve ultrasonography (US) is also valuable for demonstrating compression of the median nerve within the carpal tunnel and can additionally identify other lesions affecting the nerve at this level, such as a ganglion cyst .
Although patients with CTS may not have overt motor involvement, clumsiness and impairment of fine motor functions are frequently observed. It has been suggested that these findings may result from impaired sensory feedback required for motor coordination or from a central sensory-motor integration disorder
Changes in muscle strength in patients with sensory involvement only on electromyography can be measured precisely using hand-held dynamometers . Hand-held dynamometers have long been used for the objective assessment of muscle strength. In recent years, electronic versions of these devices have been developed. In our study, muscle strength will be objectively assessed using the "Lafayette Manual Muscle Tester®" by measuring the force exerted by the relevant muscle group during isometric contraction against the measurement pad of the device. Quantitative parameters, including peak force, mean force, and time-dependent changes in force, will be obtained.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CTS-affected hand | Participants with unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria will be admitted to this group. Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities. The comparison of the peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be performed. Needle electromyography will be performed when necessary to exclude radiculopathy. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®). | ||
| Healthy Control Group | Participants without carpal tunnel syndrome will be included in this group. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®). |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Age ≥18 years. * Female sex. * Unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria. * Sensory or motor involvement on electromyography (EMG). * Paresthesia, pain, or numbness in the area of the hand innervated by the median nerve for more than 3 months. * Presence of Tinel's and Phalen's signs. Exclusion Criteria: * History of hand surgery. * Severe cardiovascular disease. * Neuromuscular disease affecting muscle strength. * Gout. * History of hand trauma. * History of rheumatoid arthritis or osteoarthritis of the hand or wrist. * Pregnancy. * Cervical radiculopathy or any upper extremity neuropathy other than carpal tunnel syndrome.
| Facility | City | Country | Status |
|---|---|---|---|
| Bezmialem Vakif University | Istanbul, Fatih | Turkey (Türkiye) |